- Exclusive rights outside US, China cover commercialisation and manufacturing of lerodalcibep
- EU-approved Lyrokaul offers once-monthly dosing and up to six months’ ambient storage
- PCSK9 inhibitor market outside US and China stood at $3.7 billion, growing at 38% CAGR
- Sun Pharma to pursue regulatory approvals in licensed territories where the drug is yet to be approved
- Deal adds a potentially significant cardiovascular-care platform to Sun Pharma’s innovative medicines portfolio
NE PHARMA BUREAU
MUMBAI (INDIA)/CINCINNATI, OHIO (US), SEPT 28
In a move that expands its footprint in innovative cardiovascular medicines, Sun Pharmaceutical Industries Ltd and US-based LIB Therapeutics Inc. have entered into an exclusive global licensing, commercialisation and manufacturing agreement for lerodalcibep, a once-monthly PCSK9 inhibitor for lowering LDL cholesterol.
The agreement gives Sun Pharma rights to commercialise and manufacture lerodalcibep worldwide excluding the United States and China. Sun Pharma will also pursue regulatory approvals in licensed territories where the medicine has not yet been approved. The company’s September 28 regulatory disclosure confirms the licensing announcement.
The deal comes shortly after the European Union authorised lerodalcibep under the brand name Lyrokaul. The European Commission’s Union Register records the centralised authorisation procedure in September 2026.
“Once-monthly lerodalcibep dosing, with robust LDL-C reduction and the added benefits of a small-volume injection and six-month ambient storage, simplifies treatment for patients and offers greater convenience,” said Kirti W Ganorkar, Managing Director, Sun Pharma.
“This agreement marks a significant step in strengthening our global Innovative Medicines portfolio, particularly in cardiovascular care,” he added.
A growing cardiovascular opportunity
The partnership gives Sun Pharma access to a rapidly expanding PCSK9 inhibitor market. According to IQVIA data cited by the companies, the market outside the US and China reached $3.7 billion in MAT Q2 2026, recording a 38% CAGR over the preceding two years. Europe alone accounted for $2.9 billion.
LIB Therapeutics said the agreement could broaden access to lerodalcibep among patients with cardiovascular disease or those at high cardiovascular risk who require substantial additional LDL-C reduction despite existing treatment.
“Sun Pharma’s international presence and experience in building global innovative brands make it an ideal partner to bring lerodalcibep to more patients,” said Evan Stein, MD, PhD, Chief Operating and Scientific Officer and co-founder, LIB Therapeutics.
Designed for sustained LDL-C reduction
Lerodalcibep is a novel antibody-mimetic biologic and recombinant fusion protein that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), helping sustain reductions in LDL-C, commonly referred to as “bad” cholesterol.
Lyrokaul is administered as a 300 mg/1.2 mL subcutaneous injection once a month. Its EU authorisation covers adults with primary hypercholesterolaemia, including heterozygous familial hypercholesterolaemia, and mixed dyslipidaemia, as an adjunct to diet.
It may be used with a statin or other lipid-lowering therapy when patients do not reach LDL-C goals on the maximum tolerated statin dose, or alone/in combination with other lipid-lowering medicines when statins are not tolerated or are contraindicated.
Convenience beyond the clinic
One of the product’s distinguishing features is its storage flexibility. After removal from refrigeration, Lyrokaul can be stored in its original carton at room temperature up to 25°C for up to six months, according to the supplied EU product information.
The medicine is already approved in the US under the brand name Lerochol, although the US market is excluded from Sun Pharma’s licensing territory.
Financial terms remain confidential
Under the agreement, LIB Therapeutics will receive an upfront payment, future milestone payments and royalties based on net sales in the licensed territories. Other financial terms have not been disclosed.
For Sun Pharma, the transaction marks an expansion of its innovative medicines portfolio into a cardiovascular segment where persistent gaps remain between recommended LDL-C targets and real-world attainment.
The company said the partnership is intended to broaden access to innovative lipid-lowering treatment across Europe and other licensed markets.
